In July 2025, HSA launched the new online platform SHARE (Singapore Health Product Access and Regulatory E-System) for Medical Devices product registration and licences submission which replaced the previous online platform MEDICS. This new SHARE portal is part of HSA’s ongoing commitment to streamline regulatory processes and make it easier for businesses to comply with regulations.
Due to the launch of SHARE portal, multiple Medical Device Guidances were updated by HSA consecutively over the months, to provide clarity to the submission process. The updated guidelines include the following:
- GN-15: Guidance on Medical Device Product Registration
- GN-34: Guidance Document for IVD Analysers
- GL-08: Regulatory Guidelines for Laboratory Developed Tests
- GN-17: Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT
- E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in SHARE
- GN-18: Guidance on Preparation of a Product Registration Submission for InVitro Diagnostic Medical Devices using the ASEAN CSDT
- E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based
- Submissions in SHARE
- GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices
- GN-22: Guidance for Dealers on Class A Medical Devices Exempted from Product Registration
- GN-21: Guidance on Change Notification for Registered Medical Devices
- GN-24: Guidance on the Change of Registrant
- GN-35: Guidance on Special Access Routes
- GN-32: Guidance for Importation of Unregistered Medical Devices for Exhibition in Singapore
To view details of the updates to each guideline, please visit HSA’s Medical Device Guidance page at the following link: https://www.hsa.gov.sg/medical-devices/guidance-documents